ZARAGOZA,
Spain and FRANKLIN LAKES, N.J., March 10, 2020 /PRNewswire/ -- CerTest Biotec,
along with BD (Becton, Dickinson and Company) (NYSE: BDX), a
leading global medical technology company, today announced
that the VIASURE SARS-CoV-2 Real Time PCR Detection
Kit adapted for the BD MAX™ System has been CE
marked to the IVD Directive (98/79/CE). The molecular test for
detection of COVID-19 is available to clinical laboratories in
countries recognizing the CE mark.*
"The CerTest-developed kit will bring rapid COVID-19 diagnostic
capabilities to many laboratories across Europe which desperately need the ability to
quickly identify COVID-19 patients so that proper protocols for
infection prevention can be instituted," said Nelson Fernandes, managing director of CerTest
BioTec.
The test is a real-time reverse transcriptase polymerase chain
reaction (PCR) assay for use on the fully automated BD
MAX™ System. It detects SARS-CoV-2 in clinical
samples by amplification of a fragment of the S gene of the
virus. RNA is extracted, amplified using RT-PCR and detected using
fluorescent reporter dye probes specific to SARS-CoV-2. This
VIASURE kit contains in each well all the components necessary for
real-time PCR assay in a stabilized format, as well as an internal
control to monitor PCR inhibition.
As with all CerTest tests, the VIASURE SARS-CoV-2 Real
Time PCR Detection Kit for the BD MAX™ System is
offered in a lyophilized format. Accordingly, the test comes in a
tube that snaps into the test-specific position on the BD
MAX™ ExK™ TNA extraction strip, which is
supplied by BD.
"Together with CerTest, we can offer our customers in
Europe a complete solution for
COVID-19 diagnostics. Leveraging the significant install-base of
the BD MAX System in Europe and
other countries, we hope this kit will greatly enhance capacity for
COVID-19 testing, thereby helping clinicians rapidly diagnose
patients and ultimately prevent the spread of COVID-19," said
Nikos Pavlidis, vice president of
molecular diagnostics and women's health and cancer for BD.
The BD MAX™ System is a fully-integrated,
automated platform that performs nucleic acid extraction and
real-time PCR providing results for up to 24 samples across
multiple syndromes in less than three hours.
VIASURE SARS-CoV-2 Real Time PCR Detection Kit for the BD
MAX™ System is sold through BD's network and it
is not available for sale in the United
States. To locate an authorized BD representative or request
information, visit: www.bd.com or www.certest.es
*VIASURE SARS-CoV-2 Real Time PCR Detection Kit is
not available for sale in the U.S. Product availability may differ
in different countries, please contact your local BD
representative.
About CerTest
CerTest Biotec is a European company established in
2002 for the development and manufacturing of in vitro diagnostic
medical devices.
Today, CerTest is a global company structured around
5 business units offering one of the widest portfolios for human In
Vitro Diagnostic. The company bases its future on a strong
technical knowledge and expertise in the detection of human
diseases.
CerTest last generation laboratories,
state-of-the-art technical equipment and skilled professionals are
the keys for providing reliable solutions for the medical
diagnostic professional.
About BD
BD is one of the largest global medical technology companies in
the world and is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. The company
supports the heroes on the frontlines of health care by developing
innovative technology, services and solutions that help advance
both clinical therapy for patients and clinical process for health
care providers. BD and its 65,000 employees have a passion and
commitment to help enhance the safety and efficiency of clinicians'
care delivery process, enable laboratory scientists to accurately
detect disease and advance researchers' capabilities to develop the
next generation of diagnostics and therapeutics. BD has a presence
in virtually every country and partners with organizations around
the world to address some of the most challenging global health
issues. By working in close collaboration with customers, BD can
help enhance outcomes, lower costs, increase efficiencies, improve
safety and expand access to health care.
*BD and BD MAX trademarks are property of BD (Becton, Dickinson
and Company).
*VIASURE is a registered trademark of CerTest Biotec,
S.L.
Contacts:
|
|
Nelson
Fernandes,
|
|
CerTest Biotec
Managing Director
|
|
(+34) 976 520
354
|
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nfernandes@certest.esn
|
|
|
|
Troy
Kirkpatrick
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.617.2361
|
201.847.5378
|
troy.kirkpatrick@bd.com
|
monique_dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)